safety and tolerability of liraglutide in healthy volunteers and subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after single and multiple doses of nnc 90-1170 (liraglutide) in healthy volunteers and in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * healthy volunteers * healthy subjects aged 18-45 years inclusive * healthy subjects are defined as individuals free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results * women who are not of childbearing potential * signed and dated written informed consent obtained * body mass index (bmi) within the range 19-30 kg/m\^2, inclusive * subjects with diabetes * subjects aged 40-70 years inclusive * subjects diagnosed with type-2 diabetes and a duration of diabetes of more than 12 months * women who are not of childbearing potential * signed and dated written informed consent obtained * fasting c-peptide at least 0.3 nmol/l and blood glucose at least 7 mmol/l * subjects currently on diet and/or oha (oral hypoglycemic agents) for at least six months * body mass index (bmi) below 35 kg/m\^2 * hba1c (glycosylated haemoglobin) below 11% * stable on current medication for at least 3 weeks prior to dosing in this study exclusion criteria: * healthy volunteers * clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation * clinically relevant abnormalities of laboratory values or ecg at the screening evaluation * presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous * blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmhg systolic, 40-90 mmhg diastolic: heart rate 40-100 beats/min * history of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women) * alcohol intake within 48 hours prior to visit * evidence of drug abuse on urine testing at study entry * the subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period * hepatitis b surface antigen (hbsag), hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies * history of significant drug allergy or drug hypersensitivity * subjects with diabetes * use of any drug (except for oral hypoglycaemic agents (ohas)) which in the investigator's opinion could interfere with the blood glucose level (e.g. insulin, systemic corticosteroids, thiazides) * recurrent severe hypoglycaemia as judged by the investigator * clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation * clinically relevant abnormalities of laboratory values or ecg at the screening evaluation * presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous * blood pressure and heart rate in seated position at the screening examination outside the ranges 110-160 mmhg systolic, 60-90 mmhg diastolic: heart rate 40-100 beats/min * history of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women) * alcohol intake within 48 hours of visit * evidence of drug abuse on urine testing at study entry * the subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period * hepatitis b surface antigen (hbsag), hepatitis c antibodies * history of significant drug allergy or drug hypersensitivity